Improving access to generic & biosimilar medicines in Bulgaria and in the EU 1 Adrian van den Hoven...

Improving access to generic & biosimilar medicines

in Bulgaria and in the EU

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Adrian van den HovenDirector General

EGA – European Generic medicines Associations

Sófia, 14th November 2013

Patient access to high-quality medicines

Supporting the Generic medicines market

Savings through the use of Biosimilar medicines

Boosting Manufacturing

Executive summary

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Conclusion

The healthcare environment

The European Generic Medicines and Biosimilar Medicines Association (EGA) is at the heart of Europe’s medicine industry and is essential to EU Public Health.1

Patients

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Quality

Value

Sustainability

Partnership

Generic medicines bring savings of

35€ Bn p.a. in the EU 28

Generic medicines account for almost

54%

More than 1000 generic companies directly

employing 150,000European citizens

One of the most

competitive sectors in Europe

volume

7% of turnover to R&D

exporting to more than

100 countries outside the EU

value21%

The EU generic medicines industry is highly committed to Europe’s health

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7 key therapy areas: 60% price decrease/ 200% increase in number of treatment days

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EVOLUTION OF EUROPEAN VOLUME WEIGHTED PRICE/TREATMENT DAY VS NUMBER OF TREATMENT DAYS ACROSS 7 THERAPY AREAS

VOLUME WEIGHTED PRICE/TD NUMBER OF TREATMENT DAYS

© 2013, IMS HEALTHSelected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012

Generics provide increased access to affordable medicines

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EVOLUTION OF EUROPEAN NUMBER OF TREATMENT DAYS OF GENERICS VS. ORIGINAL BRANDS ACROSS 7 THERAPY AREAS

GENERIC NO. OF TREATMENT DAYS NON-GENERIC NO. OF TREATMENT DAYS

6© 2013, IMS HEALTH

Selected therapy areas: Angiotensin II antagonists, anti-depressants, anti-epileptics, anti-psychotics, anti-ulcerants, cholestrol regulators and oral anti-diabetics. Source: IMS MIDAS, MAT 09 2012

Projection for EU28, 2013

ATC classes: A10 drugs used in diabetes

Generic share: 54%

Total number of treated patients: 36 million Patients treated by generic medicine: 20 million

Source: International Diabetes Federation (IDF), Diabetes Atlas; European Community Health Indicators (ECHI) Internal estimate based on IMS MIDAS

Prevalence: 8.5%, adult population aged above 15 years

Diabetes patients treated in Europe

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Projection for EU28, 2013

ATC classes: C2 antihypertensives

Generic share: 59%

Total number of treated patients: 82 million Patients treated by generic medicine: 48 million

Prevalence: total hypertension 40% of population aged above 15 years;19% - treated hypertension,

Hypertension patients treated in Europe

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Source: Euro Barometer; BMC Public Health - Internal estimate based on IMS MIDAS

Generic Medicines generate savings

9Source: European Commission and Mrazek & Frank, 2004 in WHO - Health policy responses to the financial crisis in Europe report).

“(…)policies promoting the use of generic medicines are often at the forefront in the attempt to increase the cost-effectiveness of medicinal products”. EC-FIN

“Policies to promote greater use of generic medicines are likely to lower pharmaceutical expenditure and enhance efficiency” –WHO Report

Lipitor generics help NHS save £1m per day (in the UK), Pharma Times, 15 May

The NHS saved more than £350 million in the first 12 months after the patent expiration of Pfizer’s Lipitor last year.

(…), now costs just £1.89 – the price tag for Lipitor comes in at £13 for the same pack size and dose, according to the British National Formulary.

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Executive summary

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Conclusion


Avg. EU-27 health exp. Growth rates from 2000 to 2011, public and total

12Source: OECD, 2013

In 2010, health spending fell in Europe for the first time since 1975

Health expenditure by function of care, OECD avg., annual growth

13Source: OECD, 2013

Pharmaceutical sector cuts

Disruptive change :unsustainable market environment

National +EU levelNational level

Well-intended EU legislation complexity

and cost

External reference pricing

Discounts/rebates, payback and clawback policies

Price freezes and price cuts

Retail tendering

Governments take short-term cost

measures

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Executive summary

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Conclusion


Making the Generic medicines market grow

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Increase savings for the

Bulgarian health system

Making the Generic medicines market grow

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External Reference PricingNot for generics

Key risks when introducing ERP:1. Generic medicines prices below profitability level2. Artificial downward price spiral (procurement and

tendering)3. Price linkage – ERP is applied twice4. Inability to launch generics in some markets5. Divergences in updating price lists

WHO : ERP not appropriate for generics

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Executive summary

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Conclusion


Cumulative savings for 8 EU countries, 2007-2020: between

€11.8 up to 33.4 b€1

Emerging markets for biologic medicines represent

$15Bn opportunity

Emerging markets for biologic medicines represent

$15Bn opportunity

Specialty drugs are

forecasted to be 50% of all drug expenditure in

20182

Specialty drugs are

forecasted to be 50% of all drug expenditure in

20182

Biosimilar Filgrastim increased patient access

by 44% in the UK3

Biosimilar Filgrastim increased patient access

by 44% in the UK3

Biosimilar medicines as a major opportunity

for EU

European biosimilar medicines industry needs strong support to develop

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Source: 1. IGES study – 2. Prime Therapeutics & University of Minnesota College of Pharmacy, poster presented at AMCP San Diego April 4 - 3: UK Filgrastim Volume (in Std. Units) increased by 44% between 2009 and 2012

Adoption of biosimilars has increased access and generated savings in the major EU countries

Estimates put annual savings in excess of €120 million in these countries

Total 10 countries443M $

MAT 03/2013Fast uptake at launch, now mature

Consistent uptake

Cultural resistance but change undergoing

Fast growing due to market trends

Biosimilar replaced originator supply

Source: IMS MIDAS, MAT 03/2013

© 2013, IMS HEALTHGeneric medicines and biosimilars generating savings beyond the medicines bill21

Future biosimilars offer more saving among newer therapies: anti-TNF and Mabs

Source: IMS MIDAS, Mar 2013

Existing

(It includes old generation insulins which are unlikely to be targeted by biosimilar players)

EU approved

© 2013, IMS HEALTHGeneric medicines and biosimilars generating savings beyond the medicines bill22

Biosimilars and the way ahead

Information for doctors : Clear, unbiased information on the scientific concept of biosimilars, approval process, safety and efficacy

Member States: Guidelines to incentivize physicians to prescribe biosimilars; reimbursement rules for biosimilars uptake

Reimbursement: remove hurdles or delays to pricing and reimbursement approval to increase savings and patient access

Advanced Manufacturing Rule: allow European based industry to compete early in emerging markets; Bulgaria 10 % of EU manufacturing





Executive summary

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Conclusion


European countries with generic medicines R&D and manufacturing*

European countries with generic medicines manufacturing*

European Countries with manufacturing sites of EU approved biosimilars**

Europe is the global hub for high-quality generic and biosimilar medicines

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Source: *EGA Internal survey - **EMA

Industrial PolicyEmerging market opportunities

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Emerging markets : 18% to 28% of the global medicines market from 2010- 2015

Source: IMS Health 2011

Market Loss of EU Generic and Biosimilar Medicines Industry

Period of market loss to EU companies

Date of international competition

20 year patent + Up to 5 year SPC





Executive summary

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Conclusion


Jobs and Growth

Generate savings

Increase patient access

Stronger collaboration is needed to foster industry and to compete at global level

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It is time to support the generic and biosimilar medicines industries

It is time to support the generic and biosimilar medicines industries

Conclusion

Medicines provide huge value to patients and healthcare systems

Stability of pricing for generic and biosimilar medicines is needed

Well thought out regulations that achieve patient safety and reduce complexity are key

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благодаря

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Improving access to generic & biosimilar medicines in Bulgaria and in the EU 1 Adrian van den Hoven...

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